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This is a perspective, multicenter,randomized controlled trial to evaluate the efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in patients with locally advanced squamous cell esophageal carcinoma . Analyses of primary objective (ORR) will be done as defined in the protocol.
The primary end point of this study is objective response rate.The secondary end point is OS, PFS and the safty of drug. The primary hypothesis is the CMNa will improve ORR and thus improve OS, PFS. Assuming bilateral a=0.05, statistical power of 80%.The total sample size is 104 cases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Glycididazole | Active Comparator | Sodium Glycididazole:800mg/m2,finished in 30 minutes,within 60 minutes after intravenous drip for radiation therapy.Three times a week (once every other one day),before radiation therapy. Chemotherapy Paclitaxel:45 mg/m²,d1,week 1-6 Cisplatin:20 mg/m²,d1,week 1-6 OR Docetaxel: 75 mg / m², 1 day or divided into D1, D8 days, 21 days / cycle. Cisplatin: 75 mg / m², divided into D1-D3 days or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle. OR 5-FU: 500 mg / m² / day, divided into D1 ~ D5 for use, 21 days / cycle. Cisplatin: 75 mg / m² / day, divided into D1-D3 day or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle 3DCRT/IMRT:2.0Gy/f/day,T60Gy/30f,week 1-6 |
|
| Control Group | Placebo Comparator | Placebo:dissolved in 100mlphysiological saline(Now with chef),ivgtt,finished in 30 minutes,within 60 minutes after intravenous drip for radiation therapy.Three times a week (once every other one day),before radiation therapy, total 6 weeks course.Chemotherapy Paclitaxel:45 mg/m²,d1,week 1-6 Cisplatin:20 mg/m²,d1,week 1-6 OR Docetaxel: 75 mg / m², 1 day or divided into D1, D8 days, 21 days / cycle. Cisplatin: 75 mg / m², divided into D1-D3 days or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle. OR 5-FU: 500 mg / m² / day, divided into D1 ~ D5, 21 days / cycle. Cisplatin: 75 mg / m² / day, divided into D1-D3 day or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle 3DCRT/IMRT:2.0Gy/f/day,T60Gy/30f,week 1-6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Glycididazole | Drug | Sodium Glycididazole 700mg/m2.Three times a week (once every other one day),before radiation therapy, total 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 36 months | |
| Progression free survival | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinming Yu, Ph.D, M.D | Shandong Cancer Hospital and Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qianfoshan Hospital of Shandong | Jinan | Shandong | 250117 | China | ||
| Qilu Hospital of Shandong University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42022351 | Derived | Li X, Zhao H, Xie P, Zhu W, Liu L, Wu P, Sheng Y, Wang C, Song Y, Meng X, Zhang J, Xing L. Sodium glycididazole combined with definitive chemoradiotherapy for patients with esophageal squamous cell carcinoma: A multicenter randomized clinical trial. Precis Radiat Oncol. 2026 Feb 25;10(1):19-26. doi: 10.1002/pro6.70052. eCollection 2026 Mar. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000603632 | sodium glycididazole |
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| Placebo | Drug | Placebo:three times a week (once every other one day),before radiation therapy, total 6 weeks. |
|
| Jinan |
| Shandong |
| 250117 |
| China |
| Shandong Cancer Hospital and Institute | Jinan | Shandong | 250117 | China |
| Jining NO.1 People's Hospital | Jining | Shandong | 250117 | China |
| Liaocheng People 's Hospital | Liaocheng | Shandong | China |
| Qingdao Center Medical Group | Qingdao | Shandong | 250117 | China |
| Rizhao City People 's Hospital | Rizhao | Shandong | China |
| Fei Cheng People's Hospital | Tai’an | Shandong | 250117 | China |
| An Qiu People's Hospital | Weifang | Shandong | 250117 | China |
| The Fourth People's Hospitalof Zibo | Zibo | Shandong | 250117 | China |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |